Laboratory

/Laboratory

TRACE ELEMENTS, INC

Budalab, LLC is an exclusive distributor of Trace Elements, Inc (TX, USA), a leading provider of hair tissue mineral analysis (HTMA) laboratory services and nutritional metabolic products for doctors and health professionals of all specialties worldwide.

Trace Elements is very committed to the profession, to their clients and to their employees as witnessed by their increasing investment in highly trained personnel, on-going operations and in some of the finest modern technology available in the world. TEI is a licensed and certified clinical laboratory (Clinical Laboratory License No.: 45 D0481787 U.S. Department of Health and Human Services, State of Texas Department of Health, CLIA 1988) that undergoes regular inspections with the Clinical Laboratory Division of the Department of Health and Human Services, HCFA. TEI uses ICP-Mass Spectrometry, the most modern and expensive analytical technique to be applied to routine elemental analysis. TEI performs all testing in a trace element laboratory clean room environment, utilizes the latest microwave temperature-controlled digestion technique and has a highly skilled and professional analytical/support staff. Further, each patient result from TEI is based upon an hourly National Institute of Standards and Technology (NIST) traceable standard curve, a rigorous quality control validation for every 24 specimens and is compared to a representative reference range derived from the like analysis of an international collection of normal and “healthy” subjects. TEI also performs routine spiked sample recoveries, daily split specimen analysis and voluntarily participates in various interlaboratory test comparison (TC) surveys. Additionally, TEI like many laboratories, participates in an on-going Quality Assurance/Quality Control program and adheres to CLIA guidelines for precision, reliability and overall good laboratory practices. Needless to say, you can be assured that we stand behind our analytical data.

How is the hair analyzed?

1. Hair samples arriving at the laboratory are first cut into small pieces with surgical scissors.
2. A precisely weighed amount of hair is digested overnight in nitric and perchloric acid.
3. The following day the sample is rehydrated and placed in the measuring instrument to be assessed for minerals.

Essentially, the dissolved sample is burned at a high temperature. Each mineral gives off a characteristic spectrum or frequencies of light, which is picked up by sensitive detectors in the measuring instrument. Calibration and precise control of the flame temperature are essential to obtain accurate readings.

Trace Elements uses state-of-the-art ICP-Mass Spectrometry (Sciex Elan 6100 and 9000 models) for all trace element determinations. These multiple systems are capable of easily handling a high volume of specimens in applications such as HTMA where limits of detection requirements are in the part-per-million (ppm) and low part-per-billion (ppb) range. TEI uses the most advanced high-volume and uniform temperature-controlled microwave digestion (CEM Mars 5 Plus) technique. Microwave digestion is the method of choice for speed, reduced contamination, complete digestions, and retention of analytes to insure precise results. Trace Elements laboratory is equipped with a trace element class clean room utilizing HEPA filtration systems. The clean room ensures that air quality and temperatures are isolated in order to protect equipment and processed specimens from potential contamination. High sensitivity balances used by the laboratory for calibration/QC check standards and specimen weighing are calibrated with weight sets traceable to NIST. All stock standards used for daily calibration and Quality Control are prepared by a leading ISO 9001 certified laboratory. In addition, all standard material is sourced from NIST standard reference material. Further, the laboratory uses 18 megohm double-deionized water, sterile polypropylene wet-digestion and sampling test tubes, acid-leached, triple-rinsed miscellaneous glassware and plasticware. All glassware when used is Class A.

Trace Elements conducts daily, weekly and monthly QA/QC studies to confirm and validate all aspects of test methodology, including precision, accuracy and verifiable detection limits. Further, the laboratory is continuously evaluating the different aspects of daily laboratory performance, such as; reagents, QC reference materials, split specimen analysis, double-blind samples, spiked samples, calibration-verification studies and routine daily monitoring of patient data trends, before, during and after each daily analytical run. This attention to detail assures that our clients are receiving data obtained by the highest standards. Additional audits involve personnel training, laboratory reporting, safety issues, customer service, etc…

Laboratory management also utilizes an extremely comprehensive and thorough state-of-the art proprietary data management program that features automated quality control (AQC) software to assist the chief technologist and laboratory director in validating all QC test results and individual specimen test results prior to release for eventual report processing. Trace Elements successfully participates in an on-going proficiency testing program with Le Centre de Toxicologie du Quebec, which offers urine, blood and hair tissue elemental testing involving clinical laboratories that utilize high resolution instrumentation in North America and Europe. Also participating in various other interlaboratory test comparison studies, Trace Elements is committed to providing the clinician with timely, precise and reliable test data.

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